Little evidence that current interventions can benefit patients with OSMF

Abstract

Data sources: Pubmed was searched using the term 'oral submucous fibrosis' (OSF). Additional searches of the Indian and Chinese literature were conducted manually.

Study selection: Randomised controlled studies (RCTs), observational studies, or case series reports that included individuals of any age with confirmed diagnosis, by clinical examination and/or biopsy of OSF. Types of interventions included habit intervention, surgical procedures, medical treatments (i.e. systemic, submucosal injection or topical agents), or physical therapy. Primary outcomes were objective change or improvement in maximal jaw opening, subjective change in severity of oral/mucosal burning pain, subjective change in quality of life using any questionnaire, and reduction in the rate of malignant transformation.

Data extraction and synthesis: Studies selected were evaluated independently by three reviewers using a data extraction form. Due to the heterogeneity of the studies synthesis was not conducted. The overall quality of evidence of RCTs for each outcome was assessed and reported using the GRADE approach.

Results: 50 studies were identified for inclusion. Only four of these were RCTs. The likely bias associated with these was thought to be high and therefore the authors urged caution in interpreting their conclusions. Interventions included oral pentoxifylline versus multivitamins; oral lycopene, oral lycopene with intralesional corticosteroids or an oral placebo; oral levamisole, an oral antioxidant, or oral levamisole; physiotherapy, injections with combination hyaluronidase/steroids, and a control group. Various objective and subjective outcomes improved with intervention.

Conclusions: The current evidence for the benefit of current interventions to manage OSF is weak.